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November 1, 2021

Coronavirus company news summary – FDA grants emergency approval to Pfizer/BioNTech shot in children aged 5-11, extends review of Moderna’s jab in adolescents

By Chris Lo

The US Food and Drug Administration (FDA) has granted Emergency Use Authorisation to Pfizer and BioNTech’s Covid-19 vaccine for children aged five to 11 years. Two 10µg doses of the vaccine given at a gap of 21 days are indicated for use in this age group. The EUA is based on positive results from a Phase II/III trial that enrolled nearly 4,500 children. Paediatric doses of the vaccine will begin shipping immediately, the companies said.

Meanwhile, the FDA has sought more time to conclude the review of its EUA for the use of 100µg dose of Moderna’s Covid-19 vaccine, mRNA-1273, in adolescents aged 12 to 17 years. The evaluation of the new global analysis of myocarditis risk following inoculation requires more time, the FDA notified the company, adding that the evaluation may not be finished before January 2022. Moderna said it will delay its EUA submission for a 50µg dose in kids aged six to 11 years while the adolescent review is ongoing.

The South African Health Products Regulatory Authority has granted approval to Oramed Pharmaceuticals subsidiary Oravax Medical to initiate subject enrolment in a Phase I clinical trial of its oral Covid-19 vaccine. Preparations to begin the first-in-human trial are progressing. The company’s virus-like particle vaccine acts on three surface proteins of the SARS CoV-2 virus, including those less vulnerable to mutation. This makes the shot more effective against present as well as emergent viral variants, Oramed said.

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